Recall Monitor
Health Products

IMRIS HFD100 Head Fixation Device

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Neurology
Product: IMRIS HFD100 Head Fixation Device
Issue: Medical devices - Performance
What to do: Manufacturer to contact users to arrange time to replace affected torque screw component with improved device.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
HFD100 Head Fixation Device10003936111361-000
HFD100 Head Fixation Device10003937111361-000
HFD100 Head Fixation Device10005092113802-000
HFD100 Head Fixation Device10011463113803-000
HFD100 Head Fixation Device10007237113803-000
HFD100 Head Fixation Device10007509113803-000
HFD100 Head Fixation Device10005134113803-000
HFD100 Head Fixation Device10005711113803-000

Issue

IMRIS is conducting a voluntary recall to address a potential safety risk associated with use of the HFD100 Head Fixation Device and will be completing corrective action to remove and replace the torque screw component in all HFD100 Head Fixation Devices at all affected customer sites.

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